GBS PNA FISH— 510(k) K082612

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K082612 for GBS PNA FISH, Substantially Equivalent on 2009-05-05. Applicant: Advandx, Inc.. Device class: 1.

Clearance details

Applicant: Advandx, Inc.
Product code: Code OAH
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2008-09-09
Decision date: 2009-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAH

K121991 — ENTEROCOCCUS QUICKFISH BC2013-01-07
K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT2009-07-24
K063127 — ENTEROCOCCUS FAECALIS PNA FISH2006-12-22

More clearances from Advandx, Inc.

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K101558 — GNR TRAFFIC LIGHT PNA FISH2010-12-16
K093024 — YEAST TRAFFIC LIGHT PNA FISH2010-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.